Friday the FDA expanded it’s approval of how and when carfilzomib (Kyprolis) can be used. Trumpets sounded. I counted eleven industry news outlets that led with the story. My reaction? Big yawn.
I wasn’t even going to post about it. But Saturday a half dozen more publications ran stories about it, so I felt we should discuss it. Most made it seem like Kyprolis was some new, big thing.
To start, here’s how Cancer Therapy Advisor opened their article Friday. It will give you a feel for what went down:
The U.S. Food and Drug Administration (FDA) has approved carfilzomib in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy.
The FDA also converted carfilzomib’s initial single-agent accelerated approval in the same treatment setting to a full approval...
In their haste to get Kyprolis approved (despite cardiac related safety concerns), Onyx was more than happy to allow the FDA to saddle Kyprolis with the tightest use restriction I’ve ever seen for a myeloma therapy.
Onxy didn’t care. The higher-ups there knew they’d be selling soon, and Amgen was all too happy to buy them out.
So this is simple housekeeping. Expanding on label use options will make it easier for medical oncologists to feel comfortably prescribing Kyprolis sooner and more often.
But specialists? Originally, Kyprolis was only approved to be teamed with Revlimid in combination; I believe for patients that had tried at least three different therapies. But I know a dozen patients who’s myeloma docs have started them on Kyprolis/dex alone. Dr. Tricot tried Cytoxan/Kyprolis/dex with me as induction prior to my stem cell transplant this summer. And if my platelet count is up, tomorrow I’ll be getting it in combination with pomalidomide and dex.
So big news? Not so much. Good news. Yes! Easier access could help a lot of our fellow patients.
Feel good and keep smiling! Pat